Annex 13. Item 6.7. – Model Article 10.X.10. for infection with SAV, infection with IHNV and infection with VHSV, and Article 10.4.15. for Chapter 10.4. Infection with ISAV

Model Article 10.X.10. for Chapter 10.5. Infection with SAV, Chapter 10.6. Infection with VHSV, and Chapter 10.10. Infection with IHNV

**USA COMMENTS IN RED FONT**

CHAPTER 10.X.

INFECTION WITH [PATHOGEN X]

[...]

Article 10.X.10.

Importation of aquatic animals for aquaculture from a country, zone or compartment not declared free from infection with [pathogen X]

When importing, for aquaculture, aquatic animals of a species referred to in Article 10.X.2. from a country, zone or compartment not declared free from infection with [pathogen X], the Competent Authority of the  should conduct a thorough import risk analysis~~assess the~~risk in accordance with Chapter 2.1. and when necessary consider in addition to pre-export testing in accordance with Chapter 5.5 and 5.11 and/or importing country requirements apply~~ing~~ theserisk~~mitigation~~management measures in either points 1 orand 2 below:

**RATIONALE:**The phrase “in addition to pre-export testing in accordance...” is added to emphasize and remind Competent Authorities that for animals being imported, especially from countries which have not declared freedom from specific pathogens, testing of consigned animals should be conducted prior to export. The following management recommendations are guidance to the Competent Authority in addition to import health requirements. 

Edited wording to accurately reflect the terms used in Chapter 2.1. 

1)	If the intention is to *grow out* and *harvest* the imported aquatic animals, consider applying the following:

**RATIONALE:**The terms “grow out” and “harvest” should be defined in the Aquatic Code Glossary. See Annex 15 for proposed definitions for these terms. 

Either

a) 	the direct delivery to and ~~lifelong~~ holding of the imported aquatic animals in a quarantine facility; and 

b)	before leaving quarantine (either in the original facility or following biosecure transport to another quarantine facility) 

(i) the aquatic animals are killed and processed into one or more of the aquatic animal products referred to in Article 10.X.3. or other products authorised by the Competent Authority; ~~and~~or

(ii) the aquatic animals are tested for the pathogenic agents of concern to demonstrate with 95% confidence that the pathogenic agent would be detected if present above a prevalence of 2%, using the diagnostic methods provided in the Aquatic Manual. If the results of this testing produce a positive result, the imported animals should not be released from the quarantine facility; and 

~~c)~~~~the treatment of all transport water, equipment, effluent and waste materials to inactivate [pathogen X] in accordance with Chapters 4.4., 4.8. and 5.5.~~

~~Or~~

~~d)~~~~apply the requirements of Chapter 4.Z.~~

**RATIONALE:**

(a) Animal populations that can demonstrate freedom at the compartment level (e.g., at the quarantine facility) should be able to be released for further grow out. We disagree that quarantine needs to be lifelong.

(b) There should be two end-point options for these animals intended for further grow out and harvest. If freedom cannot be demonstrated at the compartment level, then the animals should stay in quarantine (option “i.” proposed); however, if population freedom or equivalency with the health status of importing country can be achieved, then those animals should be able to be released from quarantine (option “ii.” proposed). 

(c) Removal of this option is needed because it redundant to the guidance inserted into Article 10.X.10. above with 5.5 and 5.11 from the Aquatic Code. 

(d) This text should be removed because Chapter 4Z is specific to animals being used as broodstock, which is covered in “2)” below and is not applicable to this section on grow out and harvest.  

OR

2) 	If the intention is to use the imported animals as broodstock to establish a new stock for aquaculture, to consider applying the following:

**RATIONALE:**Edited for clarity. 

Either

~~a)~~~~In the~~exporting country~~:~~

~~i)identify potential source populations and evaluate their~~~~aquatic anima~~l~~health records;~~

~~ii)test source populations in accordance with Chapter 1.4. and select a founder population (F-0) of~~~~aquatic animals~~~~with a high health status for infection with [pathogen X].~~

**RATIONALE:**Edited to remove the recommendations for “exporting” countries versus “importing” countries because exporting countries cannot control for what or how imported animals will be used in the importing country or what criteria would meet the requirements for all importers. Instead, the guidance in this section should focus on how the importing country should handle these imports.

a)~~b)~~ in the importing country:

i)	import the F-0 population directly into a quarantine facility;

ii)	Prior to spawning, test the F-0 population for [pathogen X] in accordance with Chapter 1.4. to determine their suitability as broodstock. Only animals which test negative for pathogens should be considered eligible as broodstock.

iii)	Disinfect fertilized eggs according to appropriate chapter guidance. ~~produce a first generation (F-1) population in~~quarantine~~;~~

iv)	produce and culture the F-1 population in quarantine for a duration sufficient for, and under conditions that are conducive to, the clinical expression of infection with [pathogen X], and sample and test for [pathogen X] in accordance with Chapter 1.4. of the Aquatic Code and Chapter 2.3.6. of the Aquatic Manual;

v)	if [pathogen X] is not detected in the F-1 population, it may be defined as free from infection with [pathogen X] and may be released from quarantine;

vi)	if [pathogen X] is detected in the F-1 population, those animals should not be released from quarantine ~~and should be killed and disposed of in a biosecure manner in accordance with Chapter 4.8.~~

Or

c)	apply the requirements of Chapter 4.Z.

[...]

**RATIONALE:**Edits to “i)”, “ii)”, and “iii)” clarify when certain activities should be conducted.  

iv) This recommendation to kill positive F1 animals is beyond the scope of WOAH. We feel it is inappropriate for WOAH to tell members they must kill animals when there are other risk-based approaches available. The Aquatic Code/Manual should be a resource to members and the international community for the science and options. The Competent Authority should ultimately determine how best to handle these situations given an appropriate risk assessment. 

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